drugset / Trial / NCT02460276

A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma

NCT02460276 ↗

NaSingle-groupOpen-labelTreatment

Summary

In this trial, patients with mantle cell lymphoma will be included, treatment with lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12 cycles, cycle length 28 days. Patients with complete remission, partial response or stable disease will enter a maintenance phase with treatment with ibrutinib and rituximab until progression of disease. The primary objective is to evaluate overall response rate, based on PET and CT.

Timeline

Start
2015-04
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 560 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 1400 mg Intravenous

Indications